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Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes (BEGIN™)

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT01076647
First received: February 25, 2010
Last updated: February 23, 2011
Last verified: January 2011
History of Changes

February 25, 2010
February 23, 2011
March 2010
December 2010   (final data collection date for primary outcome measure)
HbA1c change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01076647 on ClinicalTrials.gov Archive Site
Body weight change from baseline [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Comparison of NN1250 With Insulin Glargine in Subjects With Type 2 Diabetes
A Trial Comparing the Efficacy and Safety of NN1250 and Insulin Glargine in Subjects With Type 2 Diabetes (EASY™)

This trial is conducted in Europe and North America. The aim of this clinical trial is to compare NN1250 with insulin glargine, as add-on to subject's ongoing treatment with metformin and/or DPP-4 inhibitors, in patients with type 2 diabetes being treated with oral anti-diabetic drugs (OADs).
Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Diabetes Mellitus, Type 2
  • Drug: NN1250
    NN1250 will be injected subcutaneously (under the skin) once daily three times weekly
  • Drug: insulin glargine
    Insulin glargine will be injected subcutaneously (under the skin) once daily administered at the same time each day
  • Experimental: A
    Intervention: Drug: NN1250
  • Active Comparator: B
    Intervention: Drug: insulin glargine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
467
December 2010
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • The subjects must be diagnosed with type 2 diabetes mellitus for at least 6 months
  • Insulin naïve subjects
  • Current treatment: metformin alone or metformin in any combination with other oral anti-diabetic drugs (OADs)
  • HbA1c between 7.0 and 10.0 % (both inclusive)
  • BMI (Body Mass Index) below or equal to 45.0 kg/m2

Exclusion Criteria:

  • Use of thiazoledinediones (TZDs), exenatide or liraglutide within the last 3 months prior to trial start
  • Cardiovascular disease within the last 6 months
  • Uncontrolled treated/untreated severe hypertension
  • Pregnancy, breast-feeding, the intention of becoming pregnant or not using adequate contraceptive measures
  • Cancer and medical history of cancer
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Bulgaria,   Canada,   France,   Hungary,   Netherlands,   Romania
 
NCT01076647
NN1250-3718, U1111-1112-8770, 2009-011399-31
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk
Not Provided
Study Director: Kirsten Jøns Novo Nordisk
Novo Nordisk
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP